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AzTrials

Disorder of ConsciousnessPhase 3STIMCOMNCT03007784

Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients

A Phase 3 study testing transcranial direct current stimulation (tDCS) / Comparison of current intensities in people with Disorder of Consciousness and Minimally Conscious State, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
transcranial direct current stimulation (tDCS) / Comparison of current intensities
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteFrance
Study dates
Jan 2017to Jan 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities)
  • Patients with stable clinical examination
  • Age between 18 and 80 years
  • Brain injury confirmed by cerebral imaging (MRI or TDM)
  • Disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)

Who cannot join

  • Status epilepticus
  • Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia)
  • Pregnancy
  • Patients underage

Trial locations and contacts

1 site in 1 country.

Jacobo Sitt, MD PhD contact

+33 1 57 27 43 17

jacobo.sitt@icm-institute.org

Bertrand Hermann, MD Msc contact

+33 1 57 27 43 14

bertrand.hermann@icm-institute.org

France1 site, 1 recruiting

  • Groupe Hospitalier Pitié-Salpêtrière

    Paris, 75013

    Lionel Naccache, MD, PhD, +33157274314, lionel.naccache@gmail.com

    Recruiting

Other trials in France

About this study

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown.

This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.

Read the detailed description

This study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tDCS intensity, totalizing a number of 10X2 stimulation sessions of 20 minutes each).

Being tested
transcranial direct current stimulation (tDCS) / Comparison of current intensities
Keywords
Consciousness, Disorder of consciousness, Minimally conscious state, Vegetative state, Exit-MCS, Transcranial direct current stimulation (tDCS), CRS-R, EEG, Cognitive ERPs
Medical subject headings
Consciousness Disorders, Persistent Vegetative State, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct current stimulation (tDCS) / Comparison of current intensitiesDevice

Study groups in NCT03007784
Study groupRoleWhat they receive
2 mA anodal tDCS stimulationExperimentalAnodal tDCS stimulation at 2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks
Receives: Device: transcranial direct current stimulation (tDCS) / Comparison of current intensities
0.2 mA anodal tDCS stimulationActive comparatorAnodal tDCS stimulation at 0.2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks
Receives: Device: transcranial direct current stimulation (tDCS) / Comparison of current intensities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of the Coma Recovery Scale-Revised score according to tDCS current intensity (2mA versus 0.2mA)

    Comparison of the CRS-R score at the tenth day of 0.2mA stimulation (Day14 or Day28) with the score at the tenth day of 2mA stimulation (Day14 or Day28)

    Measured: Last Day of 0.2mA session (Day 14th or Day 28th) versus Last Day of 2mA session (Day 14th or Day 28th)

  2. Change from baseline of the Coma Recovery Scale-Revised score after 2mA tDCS current intensity

    Comparison of the CRS-R score at the tenth day of 2mA stimulation (Day14 or Day28) with the score at baselne (Day1)

    Measured: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

  3. Change from baseline of the Coma Recovery Scale-Revised score after 0.2mA tDCS current intensity

    Comparison of the CRS-R score at the tenth day of 0.2mA stimulation (Day14 or Day28) with the score at baselne (Day1)

    Measured: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

Secondary outcomes (6)

  1. IChange of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity

    Statistical comparison of local (MMN, automatic CNV) and global (P3b; modulation of CNV) ERP effects recorded after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 0.2mA tDCS stimulation (Day 14th or Day 28th)

    Measured: Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th)

  2. Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 2mA tDCS current intensity

    Statistical comparison of local (MMN, automatic CNV) and global (P3b; modulation of CNV) ERP effects recorded at baseline (Day 1) and after 10 days of 2mA tDCS stimulation

    Measured: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

  3. Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 0.2mA tDCS current intensity

    Statistical comparison of local (MMN, automatic CNV) and global (P3b; modulation of CNV) ERP effects recorded at baseline (Day 1) and after 10 days of 0.2mA tDCS stimulation

    Measured: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

  4. IChange of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity

    Statistical comparison of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain 2014) after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 0.2mA tDCS stimulation (Day 14th or Day 28th)

    Measured: Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th)

  5. Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity

    Statistical comparison of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain 2014) at baseline (Day 1st) and after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th)

    Measured: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

  6. Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 0.2mA tDCS current intensity

    Statistical comparison of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain 2014) at baseline (Day 1st) and after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 0.2mA tDCS stimulation (Day 14th or Day 28th)

    Measured: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03007784
Sponsor's protocol ID
SC20160427
Acronym
STIMCOM
Status last verified
Jan 2017
First submitted
22 Dec 2016
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing transcranial direct current stimulation (tDCS) / Comparison of current intensities in people with Disorder of Consciousness and Minimally Conscious State, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacobo Sitt, MD PhD (+33 1 57 27 43 17, jacobo.sitt@icm-institute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the Coma Recovery Scale-Revised score according to tDCS current intensity (2mA versus 0.2mA) (time frame: Last Day of 0.2mA session (Day 14th or Day 28th) versus Last Day of 2mA session (Day 14th or Day 28th)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03007784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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